Recruiting
Early Phase 1

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06175403

Conditions

Excessive Weight Gain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Niacin

Study Details

Brief summary:

Adults who gain most of their excess weight in the abdominal area typically do not respond to things that "turn off" fat cells the same way as lean people. The researchers are trying to understand why fat tissue responds differently in people with different body types.

Conditions

Excessive Weight Gain

Study ID

NCT06175403

Start date

Jan 1, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo CRTU for at least 3 days prior to study.
  • Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2.
  • Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) > 0.85 and/or increased visceral fat by single slice CT scan, usually with > 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of > 0.30, and/or biochemical evidence of metabolic syndrome as defined by ATP III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of > 0.95 and/or increased visceral fat (visceral fat area > 180 cm2 or a visceral/total fat abdominal ratio by CT of > 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.
  • Female subjects are eligible if they meet the following criteria: are not pregnant or nursing; all women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug; all women of childbearing potential will use an appropriate contraceptive method, including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study. They will confirm use of one of these methods.
  • Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or > than five half-lives of the compound, whichever is longer: if Yes look at consent form and f/u visits: current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude;
  • Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks.
  • Previous labs: HbA1C < 6.5% for non-diabetic UBO; Fasting glucose < 126 mg/dl for non-diabetic UBO; Hb ≥ 11.0 for women and ≥ 12 for men; platelets > 100 000.

Exclusion Criteria:

  • Individuals with a history of a disease process such as: ischemic heart disease; atherosclerotic valvular disease; persistent blood pressure greater than 160/95 despite antihypertensive medication.
  • Smokers.
  • Concomitant use of medications that can alter free fatty acid metabolism: high dose fish oil (>3g per day), (if yes, discontinue for 6 weeks); statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; any history of use of pioglitazone; atypical antipsychotics.
  • Allergy to lidocaine.
  • Allergy to Niaspan documented by immunological testing.
  • Allergy to indocyanine green.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Upper body obesity

Subjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response.

experimental: Normal weight

Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response.

Interventions

Niacin

Intravenous administration of dose titrated from 10 µg·kg FFM-1·min-1 to 30 µg·kg for approximately 4.5 hours on one occasion

Primary outcome measure

  • Change in plasma free fatty acid (FFA) concentrations [ Time Frame: Baseline, post treatment (approximately 4 hours) ]

Central Contacts and Locations

Central contacts

Pamela Reich

507-255-6062reich.pamela@mayo.edu

Kelli Lytle, PhD

lytle.Kelli@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55904

Contacts

Pamela A. Reich

507-255-6062reich.pamela@mayo.edu

Kelli A Lytle, PhD

lytle.kelli@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-13.